Method of dissecting tissue

ABSTRACT

A method of dissecting tissue includes inserting a magnetized catheter into a urethra; magnetically pushing a tool away from the urethra with the magnetized catheter; and dissecting tissue posterior of the urethra with the tool.

BACKGROUND

Urinary incontinence affects about 200 million people worldwide andabout 25 million people in the US. Urinary incontinence in women can beassociated with a prolapse of one or more pelvic organs, which can arisefrom a weakness in the tissues/muscle of the pelvic floor. Urinaryincontinence in men can arise after surgical treatment of the prostateglade, which treatment can include removal or weakening of the prostaticsphincter associated with the urinary urethra.

One treatment for urinary incontinence includes placing an artificialsphincter around a circumference of a portion of the urethra. Theartificial sphincter operates to compress the urethra to selectivelycoapt or stop the flow of urine through the urethra, thus providing theuser with a continent state. The artificial sphincter can be activatedto an open position by the user, which opens the urethra and allows theuser to selectively pass urine.

Surgeons and patients would welcome advances in the treatment of urinaryincontinence.

SUMMARY

One aspect provides a surgical system adapted for dissection of tissuearound an organ or around a lumen. The surgical system includes a tissuedissection tool and a catheter. The tissue dissection tool includes ashaft connected between a handle and a tissue dissection head. At leastthe tissue dissection head of the tissue dissection tool is magnetizedto a first polarity. The catheter is insertable into the organ or thelumen, with a wall of the catheter magnetized to the first polarity.When the catheter is inserted into the organ or the lumen, the firstpolarity of the catheter is configured to repel the first polarity ofthe tissue dissection head of the tool away from the catheter and awayfrom in the urethra.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments andtogether with the description serve to explain principles ofembodiments. Other embodiments and many of the intended advantages ofembodiments will be readily appreciated as they become better understoodby reference to the following detailed description. The elements of thedrawings are not necessarily to scale relative to each other. Likereference numerals designate corresponding similar parts.

FIG. 1 is a perspective view of a prior art artificial urinary sphincter(AUS) system implanted in the urogenital region of a male patient.

FIG. 2 is a schematic view of one embodiment of a surgical systemoperable to place a cuff of an AUS system into a patient.

FIG. 3 is a perspective view of one embodiment of a surgical systemoperable to dissect tissue away from a blind posterior location of thepatient.

FIG. 4A-FIG. 4C are embodiments of a catheter of a surgical systemoperable to place a cuff of an AUS system into a patient.

FIG. 5A is a cross-sectional view of one embodiment of a catheter of asurgical system.

FIG. 5B is a cross-sectional view of one embodiment of a catheter of asurgical system.

FIGS. 6-14 are schematic views of embodiments of the implantation of anAUS system in the urogenital region of the patient assisted by thesurgical system illustrated in FIG. 3.

FIG. 15 is a top view of one embodiment of a kit of parts including acatheter, a dissection tool, and instructions for use.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

The features of the various exemplary embodiments described in thisspecification are suited for combination with each other, unlessspecifically noted otherwise.

Tissue includes soft tissue, which includes dermal tissue, sub-dermaltissue, ligaments, tendons, or membranes. As employed in thisspecification, the term “tissue” does not include bone.

As employed in this specification, the term “end” means endmost or thevery end point of the subject being described, and the term “endportion” means that segment that is immediately adjacent to the end ofthe subject being described.

FIG. 1 is a perspective view of a prior art artificial urinary sphincter(AUS) system 20 implanted in the urogenital region of a male patient.The AUS system 20 includes three components cooperatively attached withkink-resistant tubing: an occlusive cuff 22, a control pump 24, and apressure-regulating balloon reservoir 26. The cuff 22 is implantedaround the urethra. The control pump 24 is implanted in the scrotum of amale user. The pressure-regulating balloon reservoir 26 is implanted inthe prevesical space, for example somewhere in the abdomen. Duringimplantation of the urinary control system 20, the surgeon will dissecttissue around the circumference of the urethra in order to create aspace that allows placement of the cuff 22 around the urethra. Thesurgeon is usually able to visualize the anterior area of the urethra(that is, the front facing area in the line of sight of the surgeon) forabout 180-210 degrees around the anterior urethra. The posterior portionof the urethra is not visible to the surgeon, as it is not in the lineof sight of the surgeon. For this reason, some surgeons call thedissection of tissue away from the posterior portion of the urethra a“blind” dissection. Surgeons are exceedingly cautious when dissectingtissue away from and around the urethra to avoid the undesirable outcomeof cutting into the urethra.

Embodiments described in this application provide a surgical system anda method for dissection of tissue away from the entire circumferencearound the urethra or other organ or lumen. The surgical system includesa tissue dissection tool and a catheter, where both the tool and thecatheter are magnetized to have the same polarity. Thus, when thecatheter is inserted into the urethra, the polarity of the catheterrepels the tissue dissection head because the cutting head is at thesame polarity as the catheter. In other words, these two components areconfigured to magnetically repel—or push away—from one another. Thus,when the surgeon is conducting a blind dissection of the tissue aroundthe urethra, the surgical system of this application provides increasedassurance that the tissue dissection head will be pushed away from theposterior side of the urethra.

FIG. 2 is a perspective view of one embodiment of a surgical system 30including a tissue dissection tool 32 and a catheter 34.

The tissue dissection tool 32 (tool 32) includes a shaft 41 connectedbetween a handle 40 and a cutting surface 42 (or dissection head 42)that is located opposite of the handle 40. The tool 32 is suitablyprovided as a single blade cutting tool, scissors-like tool providedwith cutting shears, or other tool that is suitably configured todissect pelvic tissue around the urethra. One suitable tool 32 includesa right angle dissection tool with the cutting surface 42 oriented atabout 90 degrees relative to the shaft attached to the handle 40. It isacceptable to have the dissection head 42 oriented in a range between10-80 degrees relative to the shaft attached to the handle 40. At leasta portion 45 of the tool 32 is magnetized at a first polarity. Forexample, in one embodiment the cutting surface 42 is magnetized at apolarity that is the same polarity as a polarity of a magnetized portionof the catheter 34, such that the cutting surface 42 is configured tomagnetically repel away from the catheter 34.

It is acceptable to magnetize the entire tool 32 at a single polarity.In one embodiment, the handle 40 of the tool 32 is fabricated from asurgical steel or other metal acceptable to the surgical suite and theportion 45 of the tool 32 that is magnetized is fabricated from a rareearth magnet. For example, the magnetized portion 45 is provided as arare earth magnet and integrated to the handle 40. Rare earth magnetsare permanent magnets that are formed from the lanthanide elements ofmetals with ferromagnetic properties. Rare earth magnets arecharacterized as having a magnetic strength of 2-5 times greater thanferrite magnets.

The catheter 34 is configured for insertion into the urethra of thepatient. The catheter 34 includes a lumen 50 that is sized andconfigured to transport urine from the bladder. The lumen 50 extendsfrom a distal end 54 of the catheter 34 (which remains outside of thepatient/urethra) to a proximal end 52 of the catheter 34 that isinsertable into the urethra. At least a portion 55 of the catheter 34 ismagnetized to the first polarity, or the same polarity as the magneticfield of the tool 32. It is desirable that the portion 55 of thecatheter 34 that is magnetized to the first polarity is or becomeslocated in an area of the bulbar urethra when the catheter is insertedinto the urethra. The magnetized portion 55 is fabricated from one of aferromagnet or a rare earth magnet. The proximal end 52 of the catheter34 includes an opening 56 that allows urine to enter the catheter 34.The distal end 54 of the catheter 34 includes a connector that isattachable to a bag that is provided to collect the urine flowing fromthe bladder.

In one embodiment, the catheter itself is not magnetized and instead arod of magnetic metal is directed into the catheter lumen. Themagnetized rod is magnetized to the first polarity, or the same polarityas the magnetic field of the tool 32. The magnetized rod is insertedinto the patient to the area of the bulbar urethra. In this manner, themagnetized rod will repel the tool 32 away from the bulbar urethraduring tissue dissection.

The catheter 34 is suitably configured as a single use catheter, anindwelling catheter, or a modified Foley catheter. For example, oneembodiment of the catheter 34 includes an inflatable balloon 58 locatednear the proximal end 54. The inflatable balloon 58 is sized to beinflated after the catheter 34 is introduced through the urethra andinto the bladder. Inflation of the inflatable balloon 58 enlarges theend region of the catheter 34, which prevents the catheter 34 fromundesirably sliding out of the urethra.

The catheter 34 includes a lumen 50 to transport urine. It is within thescope of this disclosure to include a catheter having a magnetizedportion configured to repel the cutting surface 42 of the tool 32, wherethe catheter is a magnetized and flexible rod that does not transporturine. For example, given the duration of the surgery, it is acceptableif the magnetized catheter is inserted into the urethra to support andexpand the urethra without having a lumen to transport urine.

FIG. 3 is a schematic view of the tool 32 deployed in cooperation withthe catheter 34. The catheter 34 has been inserted into the urethra andthe inflatable balloon 58 has been expanded to maintain the catheter 34in the bladder. The tissue around and in the area of the urethra is notillustrated to allow better visualization of the tool 32.

The portion 45 of the tool 32 is magnetized to the first polarity (N)and the portion 55 of the catheter 34 is also magnetized to the samefirst polarity (N). The magnetic field of the portion 55 of the catheter34 inside the urethra is adapted to repel +R+ the magnetized portion 45of the tool 32. This aspect is particularly useful as the cuttingsurface 42 is directed posterior of the urethra. In this manner, thecutting surface 42 of the tool 32 is pushed away from the urethra as thesurgeon dissects the tissue posterior to the urethra, which allows thesurgeon to dissect tissue that is out of his/her field of view.

FIGS. 4A-4C are perspective views of embodiments of catheters.

FIG. 4A is a perspective view of a catheter 64 including one discreteportion 65 that is magnetized at the same polarity as the tool 32. Themagnetized portion 65 is located between the proximal and distal ends ofthe catheter, for example over only an extent that is less than about50% of the length of the catheter. The magnetized portion 65 includes anembedded magnetized portion located between an outside and an insidesurface of a wall of the catheter 64, where the magnetized portion 65extends around the entire circumference of the catheter 64. It isacceptable for the magnetized portion 65 to include an embeddedmagnetized portion that is located around less than an entirety of thecircumference of the catheter 64, for example along a 180 degree arcaround only a part of the circumference of the catheter 64.

FIG. 4B is a perspective view of a catheter 74 including a portion 75that is magnetized. The portion 75 that is magnetized extends oversubstantially the entire length of the catheter and 74. The magnetizedportion 75 includes an embedded magnetized portion located between anoutside and an inside surface of a wall of the catheter 64, where themagnetized portion 75 extends around the entire circumference of thecatheter 74. It is acceptable for the magnetized portion 75 to includean embedded magnetized portion that is located around less than anentirety of the circumference of the catheter 74, for example along a180 degree arc around only a part of the circumference of the catheter74.

FIG. 4C is a perspective view of a catheter 84 including a portion 85that is magnetized. The portion 85 that is magnetized is wrapped in aspiral shape around the proximal end portion of the catheter 84. Thespiral magnetized portion 85 is located between an outside and an insidesurface of a wall of the catheter. The magnetized portion 85 is suitablyembedded or molded into the wall of the catheter 84. The spiral natureof the magnetized portion 85 loops around the circumference of thecatheter 84.

FIG. 5A is a cross-sectional view of the catheter 34 taken through themagnetized portion 55. The catheter 34 includes a tubular wall 90 havingan inside surface 92 and an exterior (outside) surface 94. Themagnetized portion 55 of the catheter 34 is located between the insidesurface 92 and an exterior surface 94. The magnetized portion 55encircles the entire circumference of the catheter 34. Thecross-sectional view of FIG. 5A is taken at one segment along thecatheter 34. In some embodiments the magnetized portion 55 extends theentire length of the catheter 34. In some embodiments the magnetizedportion 55 is localized to a segment of less than about half of thelength of the catheter 34.

FIG. 5B is a cross-sectional view of one embodiment of a catheter 104.

The catheter 104 includes a tubular wall 110 including an inside surface112 and an exterior surface 114. A magnetized portion 115 of thecatheter 104 is located between the inside surface 112 and the exteriorsurface 114 and extends over and is localized to approximately half ofthe circumference of the catheter 104. During use, it is desirable toinsert the catheter 104 into the urethra with the magnetized portion 115oriented in a direction posterior relative to the urethra. In oneembodiment, a visual indicator 120 is provided on the exterior surface114 of the catheter 104 to indicate the location on the catheter 104that includes the magnetized portion 115. For example, in one embodimentthe visual indicator 120 is molded into the exterior surface 114 as acolored line. The magnetized portion 115 is located at least at aproximal portion of the catheter 104 and the visual indicator is locatedat least at a distal end of the catheter 104, which allows the surgeonto “see” the relative orientation of the magnetized portion 115.Inserting the catheter 104 into the urethra with the colored line 120facing toward the spine of the patient (e.g., oriented in the posteriordirection) ensures that the magnetized portion 115 will be locatedposterior relative to the urethra.

FIGS. 6-14 illustrate the use of the surgical system 30 and a method ofdissecting tissue away from the posterior urethra.

FIG. 6 is a schematic view of a male patient prepped for surgery. Thecatheter 34 has been inserted into the urethra. The patient is in alithotomy position with the knees elevated above the head. The surgeonforms an incision in the perineum between the scrotum and the rectum.

FIG. 7 is a schematic view of the surgeon using an instrument to dissecttissue to expose the bulbospongiosus muscle around the urethra. Onesuitable instrument is the tool 32 described above.

FIG. 8 is a schematic view of tissue dissected laterally relative to theincision. The fascia around the bulbospongiosus muscle has beendissected to expose a portion of the bulbar muscle and bulbar urethrafor access by the surgeon.

FIG. 9 is a schematic view of the urethra, and the bulbar muscle aroundthe urethra, exposed and immobilized relative to the incision. Theanterior portion of the urethra is visible to the surgeon. The catheter34 is inside the urethra and the magnetized portion 55 is present withinthe urethra at least in the location of the bulbar urethra, posterior tothe urethra. The surgeon is using his/her index finger and thumb toidentify and immobilize the urethra and the muscle around the urethra.

FIG. 10 is a schematic view of the surgical system 30 employed todissect tissue posterior of the urethra. The tool 32 is used to dissecttissue around and behind the urethra. The cutting surface 42 of the tool32 is magnetized to a first polarity. The catheter 34 is in the urethraand the magnetized portion 55 (also magnetized to the first polarity) ispresent on at least the posterior portion of the urethra. The tool isdirected posterior of the urethra and the cutting surface 42 is operatedto dissect tissue behind urethra. The magnetized portion 55 of thecatheter 34 repels and pushes away the magnetized dissection head 42 ofthe tool 32 to reduce the likelihood of the dissection head 42undesirably contacting urethra.

FIG. 11 is a schematic view of an access path formed by the surgicalsystem 30 posterior of the urethra.

FIG. 12 is a schematic view of the tool 32 employed to identify theaccess path behind and posterior to the urethra. The surgeon uses thetool 32 to identify the access path and to ensure that the axis path isopen on the backside or posterior side of the urethra. The inflatablecuff 22 will be directed through the access path behind and around theurethra.

FIG. 13 is a schematic view of a tab 150 of the cuff 22 inserted throughthe axis path behind and posterior to the urethra.

FIG. 14 is a schematic view of the cuff 22 placed around the urethra.

Embodiments provide a method of dissection tissue away from a urethra.The method includes, as described above, providing a tool 32 having atissue dissection head 42 that is magnetized to a first polarity, and acatheter 34 having a repel portion 55 that is magnetized to a samepolarity as the first polarity of the tissue dissection head 42. Themethod includes inserting the repel portion 55 of the catheter 34 intothe urethra, and dissecting tissue away from the urethra with the tissuedissection head 42 and in so doing repelling the tissue dissection head42 away from the repel portion 55 of the catheter 34 and away from theurethra.

The method additionally includes inflating a balloon 58 (FIG. 2) of thecatheter 34 and locating the repel portion 55 of the catheter 34 in abulbar urethral portion of the urethra.

The method additionally includes inserting the proximal portion 52 (FIG.2) of the catheter 34 into a bladder and draining urine out of thebladder through the urethra.

The method additionally includes dissecting tissue away from a posteriorside of the urethra and creating an open pathway around the urethra, asillustrated in FIG. 12.

The method additionally includes moving scissor portions of the tissuedissection head 42 and sizing the open pathway around the urethra toreceive an artificial urinary sphincter, as illustrated in FIGS. 13-14.

The method additionally includes dissecting tissue away from a posteriorside of the urethra with the tissue dissection head 42 obstructed from aline of sight of a user of the tissue dissection head.

FIG. 15 is a top view of one embodiment of a kit 200 of parts includingthe dissection tool 32, the catheter 34, and instructions 202 for use.The dissection tool and the catheter are suitably provided by any of theembodiments described in this application.

Although specific embodiments have been illustrated and described inthis patent application, it will be appreciated by those of ordinaryskill in the art that a variety of alternate and/or equivalentimplementations may be substituted for the specific embodiments shownand described without departing from the scope of the invention. Thispatent application is intended to cover any adaptations or variations ofmedical devices, as discussed above. Therefore, it is intended that thisinvention be limited only by the claims and their equivalents.

What is claimed is:
 1. A method of dissecting tissue, the methodcomprising: inserting a catheter into a urethra with a portion of thecatheter magnetized to a first polarity; providing a tool with a tissuedissection area, where the tissue dissection area of the tool ismagnetized to a same polarity as the first polarity; and repelling thetissue dissection area of the tool away from the catheter in the urethraand dissecting tissue posterior of the urethra with the tissuedissection area of the tool.
 2. The method of claim 1, furthercomprising: forming an access path posterior of the urethra with thetool.
 3. The method of claim 1 comprising locating the portion of thecatheter magnetized to the first polarity at a bulbar portion of theurethra.
 4. The method of claim 1 comprising inflating a balloon of thecatheter and locating the portion of the catheter magnetized to thefirst polarity at a bulbar portion of the urethra.
 5. The method ofclaim 1 comprising moving a scissors portion of the tool and opening apathway in the tissue posterior of the urethra.
 6. The method of claim 1comprising dissecting tissue away from an entire circumference aroundthe urethra.
 7. The method of claim 1 comprising inserting the catheterinto the urethra with the portion of the catheter magnetized to thefirst polarity located in an arc around a portion of a circumference ofthe catheter.
 8. The method of claim 1 comprising inserting the catheterinto the urethra with the portion of the catheter magnetized to thefirst polarity located in an approximate 180 degree arc around a portionof a circumference of the catheter.
 9. The method of claim 1 comprisinginserting the catheter into the urethra with the portion of the cathetermagnetized to the first polarity located in an approximate 360 degreearc around a portion of a circumference of the catheter.
 10. The methodof claim 1 comprising inserting the catheter into the urethra with theportion of the catheter magnetized to the first polarity located alongless than half of a length of the catheter.
 11. The method of claim 1comprising inserting a proximal portion of the catheter into the urethraand retaining a distal portion of the catheter outside of the urethra;and providing the distal portion of the catheter with a visual indicatorindicating an orientation of the portion of the catheter magnetized tothe first polarity.
 12. A method of dissecting tissue, the methodcomprising: inserting a catheter into a urethra with a portion of thecatheter magnetized; providing a tool with at least a portion of thetool magnetized; and pushing the at least the portion of the tool thatis magnetized away from the urethra and dissecting tissue posterior ofthe urethra with the tool.
 13. A method of dissecting tissue, the methodcomprising: inserting a magnetized catheter into a urethra; magneticallypushing a tool away from the urethra with the magnetized catheter; anddissecting tissue posterior of the urethra with the tool.